Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised
and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a
special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore,
the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between
plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly
in the QTc interval).
The main objective is to assess whether administration of a repeated dose of 10 and 100
mg/day , has the potential to cause QT prolongation in healthy volunteers.